On August 4, 2025, the USPTO issued a memo to patent examiners with the subject “Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101.” [1]
Much has been made of these reminders and what they might signal in terms of a possible shift in how the Office treats rejections under § 101
PatentNext Takeaway: This post highlights the FDA’s increasing regulatory efforts for artificial intelligence (AI) and machine learning (ML)-enabled medical devices (MLMDs), with a focus on managing device AI/ML updates through Predetermined Change Control Plans (PCCPs). The FDA emphasizes five guiding principles for PCCPs to ensure safety, risk management, and transparency for MLMDs throughout their lifecycle.
I am excited to announce the publication of the Intellectual Property Owner (IPO)’s paper on Patent Marking regarding Software Medical Devices.
The paper provides an in-depth analysis of patent marking laws as they apply to software and medical devices. It covers multiple jurisdictions, including the United States, the United Kingdom, France, and Germany. The paper addresses various types of medical devices and software platforms, such as external, implantable, cloud-based devices, and third-party devices. Continue Reading Patent Marking And Software Medical Devices (IPO Paper Announcement)
I am excited to announce the publication of the Intellectual Property Owner (IPO)’s white paper on “Software and Medical Device Guidance: A Global Perspective.”
The paper was authored by the IPO’s Software and Medical Device Subcommittee, which I had the honor and pleasure of leading in 2022. The Subcommittee reports to the IPO’s Software Committee. Continue Reading Announcing IPO white paper on a Global Perspective on Software and Medical Device Guidance
PatentNext Summary: Artificial Intelligence (AI) typically involves certain common aspects such as training data and AI models trained from that training data. Nonetheless, a recent Patent Trial and Appeal Board (PTAB) decision found that it is not always obvious to combine these common aspects to render an AI-based medical device invention unpatentable.Continue Reading PTAB finds Artificial Intelligence (AI) Medical Device Patent not so Obvious
PatentNext Summary: Software-based medical devices that focus on “data processing” can be patented. However, a patent practitioner should exercise care when drafting such claims. Otherwise, patent eligibility issues can arise. This article demonstrates countervailing Federal Circuit decisions that reached opposite patent eligibility conclusions for a pair of “data processing” medical device patents asserted by Cardionet, LLC against Infobionic, Inc.
The below article provides additional details. This article forms the second part of a multi-part series. The first part, focusing on patent-eligible software-based medical devices (i.e., “particular machines” and those having “underlying improvements”), may be found here: Patenting Software-based Medical Devices (Part 1).Continue Reading Patenting Software-based Medical Devices (Part 2)
PatentNext Summary: The development of modern medical devices increasingly includes the use of software for performing sophisticated diagnostic or treatment-related functions. In fact, the U.S. Food and Drug Administration (FDA) now defines specific categories of software-based medical devices that include “Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD).” In a similar way, courts review patents directed to software-based medical devices across several categories, which include inventions having “particular machines” (e.g., SiMD) and inventions purely involving software only (e.g., SaMD).
Continue Reading Patenting Software-based Medical Devices (Part 1)